Breast implant implantation method and apparatus

Abstract

A method for implanting a breast implant into a subject, the method includes: providing a sterile, flexible, elastic biodegradable bag sized to contain the breast implant; providing a sterile breast implant; inserting, using sterile handling, the sterile breast implant into the sterile bag to form a sterile breast implant assembly; closing the bag to fully enclose the implant within the bag; and implanting in a sterile manner the sterile breast implant assembly into the subject. A sterile bag, which may be provided in a kit, preferably for use with the method includes first and second chambers connected by a channel for moving a breast implant from the first chamber through the channel to the second chamber without directly touching the implant. An incision dilator may also be included with the kit or separately provided for use in a preferred embodiment of the method.

I claim: 
     
       1. A bag for retaining and sterile handling of a breast implant, the bag comprising first and second chambers each having a volume when expanded larger than the volume of the implant, the first chamber having a closable opening for insertion of the implant, the bag further having a channel connecting the chambers where the channel has a diameter smaller than either chamber but large enough to accommodate the implant when the implant is elastically deformed without damaging the implant such that the implant may be manually moved without directly touching the implant from the first chamber through the channel and into the second chamber without adversely affecting the implant, wherein the bag is made of a drug-eluting biodegradable material including at least one drug capable of at least reducing at least one of an infection and capsular contraction. 
     
     
       2. The bag of  claim 1 , wherein the at least one drug is selected from the group consisting of an antimicrobial agent, anti-inflammatory agent, anti-scarring agent, anti-neoplastic agent, a calcium channel blocker and leukotriene inhibitor. 
     
     
       3. The bag of  claim 2 , wherein the at least one drug is an antimicrobial agent. 
     
     
       4. The bag of  claim 3 , wherein the antimicrobial agent is selected from the group consisting of bacitracin, cephalexin and gentamicin, and mixtures thereof. 
     
     
       5. The bag of  claim 2 , wherein the at least one drug is a leukotriene inhibitor. 
     
     
       6. The bag of  claim 5 , wherein the leukotriene inhibitor is a leukotriene receptor antagonist selected from the group consisting of acitazanolast, iralukast, montelukast, pranlukast, verlukast, zafirlukast, and zileuton. 
     
     
       7. The bag of  claim 1 , wherein at least a portion of the bag has an outer surface selected from the group consisting of smooth, textured and crinkled. 
     
     
       8. A kit for use in handling and implanting a breast implant in a sterile manner, the kit comprising a sterile bag comprising first and second chambers each having a volume when expanded larger than the volume of the implant, the first chamber having a closable opening for insertion of the implant, the bag further having a channel connecting the chambers where the channel has a diameter smaller than either chamber but large enough to accommodate the implant when the implant is elastically deformed without damaging the implant such that the implant may be manually moved without directly touching the implant from the first chamber through the channel and into the second chamber without adversely affecting the implant, the bag being within openable sterile packaging, wherein the bag is made of a drug-eluting biodegradable material including at least one drug capable of at least reducing at least one of an infection and capsular contraction. 
     
     
       9. The kit of  claim 8 , wherein the at least one drug is selected from the group consisting of an antimicrobial agent, anti-inflammatory agent, anti-scarring agent, anti-neoplastic agent, a calcium channel blocker and leukotriene inhibitor. 
     
     
       10. The kit of  claim 9 , wherein the at least one drug is an antimicrobial agent. 
     
     
       11. The kit of  claim 10 , wherein the antimicrobial agent is selected from the group consisting of bacitracin, cephalexin and gentamicin, and mixtures thereof. 
     
     
       12. The kit of  claim 9 , wherein the at least one drug is a leukotriene inhibitor. 
     
     
       13. The kit of  claim 12 , wherein the leukotriene inhibitor is a leukotriene receptor antagonist selected from the group consisting of acitazanolast, iralukast, montelukast, pranlukast, verlukast, zafirlukast, and zileuton. 
     
     
       14. The kit of  claim 8 , wherein at least a portion of the bag has an outer surface selected from the group consisting of smooth, textured and crinkled. 
     
     
       15. A kit for use in handling and implanting a breast implant in a sterile manner, the kit comprising a sterile bag comprising first and second chambers each having a volume when expanded larger than the volume of the implant, the first chamber having a closable opening for insertion of the implant, the bag further having a channel connecting the chambers where the channel has a diameter smaller than either chamber but large enough to accommodate the implant when the implant is elastically deformed without damaging the implant such that the implant may be manually moved without directly touching the implant from the first chamber through the channel and into the second chamber without adversely affecting the implant, the bag being within openable sterile packaging, the kit further comprising a sterile breast implant, the breast implant being within openable sterile packaging, wherein the sterile packaging is selected from the same or different sterile packaging containing the bag. 
     
     
       16. A kit for use in handling and implanting a breast implant in a sterile manner, the kit comprising a sterile bag comprising first and second chambers each having a volume when expanded larger than the volume of the implant, the first chamber having a closable opening for insertion of the implant, the bag further having a channel connecting the chambers where the channel has a diameter smaller than either chamber but large enough to accommodate the implant when the implant is elastically deformed without damaging the implant such that the implant may be manually moved without directly touching the implant from the first chamber through the channel and into the second chamber without adversely affecting the implant, the bag being within openable sterile packaging, the kit further comprising a sterile breast implant encased in a sterile manner within the first chamber of the bag.